Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Acronym

Study hypothesis

The TCu380A IUD is highly effective as an emergency contraceptive.

Ethics approval

1. China: Institutional Review Board of National Research Institute for Family Planning approved on the 20th September 2005 (ref: A15046; Protocol: 96506) 2. WHO Secretariat Committee on Research Involving Human Subjects

All other centres will seek ethics approval before recruiting participants.

Study design

Prospective multicentre efficacy trial

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Contraception

Intervention

Eligible participants requesting EC up to 120 hours after unprotected intercourse and desiring long-term contraception with IUD, were given TCu380A IUD and followed for 12 months, including follow-up visits 1 and 3 months after the IUD insertion.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measures

Efficacy of the TCu380A in parous and nulliparous Chinese women

Secondary outcome measures

1. Side effects of the TCu380A in parous and nulliparous Chinese women2. Complications (such as upper genital tract infection) in the women who have IUD insertion for the purpose of emergency contraception3. Continuation rate at one year of use

Overall trial start date

01/07/1997

Overall trial end date

15/01/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. Requesting emergency contraception within 120 hour of unprotected intercourse 2. Regular menstrual cycles (24 to 42 days with no more than 5 days variation) 3. Having at least one spontaneous cycle before current cycle after recent discontinued hormonal contraception, abortion or delivery4. Desire to use IUD as long term contraceptive5. Available for follow up in one month, three months and 12 months6. Negative pregnancy test 7. Aged 18 - 44 years

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2000

Participant exclusion criteria

1. Suspected or confirmed pregnancy2. Any episode of pelvic inflammatory disease (PID) or pelvic abscess in the 12 months preceding trial admission3. Sexually transmitted infection (STI) within the past six months4. Any evidence of STI in clinical or laboratory examination during screening5. Multiple sexual partners6. Known or suspected genital tract malignancy7. Cervical or uterine malformations8. Vaginal bleeding of unknown aetiology9. Multiple uterine fibroids associated with previous menstrual anomalies10. Clinical or laboratory evidence of anaemia (haemoglobin less than 9 g/l)11. Unsure about the date of their last menstrual period (LMP needed for pregnancy risk assessment)